Zdrowie i gospodarka · 09/07/2014
FDA Releases Draft Guidance for Shedding Studies in Gene Therapy and Oncolytic Products
The FDA has made available a draft document outlining recommendations for sponsors of gene therapy and oncolytic virus or bacteria-based products to conduct shedding studies during preclinical and clinical development, following a July 2014 announcement.
Source: Federal Register — Food and Drug AdministrationOpen original release →